510(k) K954756

FIXANO I.F.O (INTERLOCKING FLEXIBLE OSTEOSYNTHESIS) SYSTEM by Ferguson Medical — Product Code HSB

K954756 is an FDA 510(k) premarket notification submitted by Ferguson Medical for the device "FIXANO I.F.O (INTERLOCKING FLEXIBLE OSTEOSYNTHESIS) SYSTEM". The FDA issued a decision of Substantially Equivalent on January 25, 1996. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. Ferguson Medical has at least 10 other 510(k) clearances on record.